Scientist II/III - Upstream Process Development - Genezen

JOB SUMMARY

The Upstream Process Development Scientist will play a crucial role in developing and optimizing upstream processes for the production of Adeno-associated viruses (AAV), Lentiviral vectors(LVV) and Retroviral vectors(RVV) at Genezen. The ideal candidate will possess a strong background in cell culture and viral vector production, with specific expertise in the use of Bioreactors. This role will involve designing and executing experiments, analyzing data, and collaborating with cross-functional teams to deliver scalable and robust processes that meet client and regulatory requirements.

This is a client-facing position that demands constant interaction and adherence to strict timelines. The individual must collaborate with cross-functional teams to establish and implement best regulatory and laboratory practices and lead the execution of complex experiments.

ESSENTIAL JOB FUNCTIONS

• Develop and optimize upstream processes for AAV, LVV and RVV production, including cell culture, transfection, infection, and harvest.
• Scale-up processes from bench-scale to pilot and production scales, ensuring consistency and robustness.
• Design and conduct experiments to improve process yield, quality, and efficiency.
• Implement process characterization studies to understand critical process parameters.
• Responsible for monitoring and reporting on process performance, identifying opportunities, and implementing changes to improve process, product safety, and product quality.
• Support process optimization efforts to increase process robustness, reduce costs, and improve viral yield and purity.
• Design and execute experiments independently: accurately record, analyze, and communicate data to clients, senior management and team members.
• Maintain open communication via one-on-one and team meetings.
• Work closely with downstream processing, analytical development, quality control, and quality assurance teams to ensure seamless process transfer and integration.
• Stay current with relevant technologies and need to be adept at identifying new approaches.
• Perform and lead single-use system design manifold, selection, implementation, configurations in between Upstream bioreactor and downstream unit operations and control strategies.
• Develop proper SOP/ SSP for Upstream processes.
• Responsible for the process transfer from or to clients and to in-house manufacturing plant.
• Maintain external technical relationships and collaborate with equipment and material suppliers.
• Stay current with the latest scientific and technological advancements in AAV production and upstream processing
• Serve as process SME for regulatory and client audits.
• Ensure safe working environment and compliance with OSHA, EHS, Quality, and cGMP procedures and policies within the assigned functional area.

SPECIAL JOB REQUIREMENTS

• Adaptability required as work schedule may change based on business needs
• Criminal background check required
• Other duties as assigned

KNOWLEDGE, SKILLS AND EXPERIENCE

PHYSICAL DEMANDS

While performing the duties of this job, the employee is required to meet the following physical demands:

Work Environment

• Frequently required to work in a BSL 2 environment with personal protective equipment/aseptic gowning
• Regularly required to work around large machinery and typical utilities seen in pharmaceutical facilities
• Occasionally exposed to moving mechanical parts; high, precarious places; toxic or caustic chemicals; hazardous waste; and risk of electrical shock
• Occasionally exposed to extremely loud noise levels
• Spending time on the floor during activity execution (maintenance, construction, commissioning and qualification) is required

Movement

•  Frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms
• Occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl

Lifting

• Frequently lift and/or move up to 10 pound
• Occasionally lift and/or move up to 25 pounds

Vision

• Frequently utilize close vision and the ability to adjust focus

Communication

• Frequently required to communicate by talking, hearing, using telephone and e-mail